FDA WARNING DOCTORS TO SHUN DRUG ABORTIONS

Carol Jouzaitis, Tribune Staff WriterCHICAGO TRIBUNE

Concerned about fast-growing interest in a new non-surgical abortion method, federal regulators warned Wednesday that the procedure remains experimental and shouldn't be copied until more research is done.

Until several weeks ago, little was known about the abortion method, which uses two inexpensive prescription drugs and provides a ready alternative to RU-486, the still-unlicensed "abortion pill."

But after a spate of publicity about the technique, including a Tribune story last month and a study published Wednesday in the Journal of the American Medical Association, dozens of other physicians are said to have expressed interest in using it.

Only a few physicians are believed to be using the procedure, and most of those are researchers doing so with the Food and Drug Administration's permission.

The technique involves two drugs, methotrexate and misoprostol, that cost about $10 and already are used for treating ailments ranging from cancer to ulcers.

While the JAMA report said the drugs were used successfully to induce abortions in a recent study-and that methotrexate works as well as RU-486 in inducing abortions-FDA Deputy Commissioner Mary Pendergast described the method as a "fairly crude therapy."

"There's more work that needs to be done," Pendergast warned in an interview. "This is not standard practice, this is not acceptable medical care. This is an experiment, and experiments have to be done under appropriate safeguards."

Despite the FDA's cautionary words, many doctors are eager to offer women an alternative to surgical abortion in light of the violence that has occurred outside abortion clinics and the scarcity of clinics in many areas of the country.

U.S. clinical trials of RU-486-the abortion pill used in France, Britain and Sweden-are under way. But the drug won't be commercially available in this country until 1996 at the earliest.

While abortion-rights advocates are waiting for RU-486, one physician who is a longtime abortion-rights activist has been advocating use of methotrexate and misoprostol for early abortions.

Dr. Richard Hausknecht, who last summer successfully performed methotrexate-misoprostol abortions on more than 100 women in his New York practice, predicted that the method would soon be used in many cities.

Since his work with the drugs was first reported in the Tribune on Sept. 12, Hausknecht said that 40 physicians in California, Hawaii, Louisiana, Florida and other states have contacted him seeking more information. He said he has sent them his protocols, or descriptions of his drug regimen.

"I think that by January, it's going to be available lots of places," Hausknecht said.

Wednesday's JAMA article focused attention on the technique and the sensitive question of when an experimental procedure should be adopted as accepted medical practice.

In the study at San Francisco General Hospital, 31 women less than eight weeks pregnant were given low doses of methotrexate and misoprostol, administered three days apart. Researchers said 90 percent experienced abortions without serious side effects, although some women complained of diarrhea, nausea or vomiting.

Some physicians familiar with methotrexate have applauded efforts to draw attention to its application as an abortifacient. Obstetricians have long relied on methotrexate as a treatment for ending dangerous ectopic pregnancies, in which the fertilized egg is lodged in the Fallopian tubes.

But others echoed the FDA's criticisms, including a researcher who co-authored the JAMA article, Dr. Mitchell Creinin of the University of Pittsburgh. He argued that despite promising results, it's too soon to judge the method's effectiveness or its possible health risks.

"I feel for patients" who want this, Creinin said. But he maintained that the procedure needed to be refined before it should be routinely used.

"I've had doctors calling me and saying they want to do this," Creinin said. "I told them, `This is crazy. There's no basis yet for doing this in clinical practice.' "

To address some of the unanswered questions, Creinin and other physicians are conducting another trial of the procedure involving 300 women in San Francisco, Pittsburgh, Wichita and Rochester, N.Y. They are investigating how to shorten the time involved in the method and how to identify patients most likely to use it successfully.

In the JAMA article, Creinin noted that a major drawback to the methotrexate-misoprostol method was the length of time required for the abortion to occur in some women. While two-thirds of the women aborted the same day as they received the misoprostol, one-third of the abortions took an average of 28 days.

Presumably, many women and physicians would consider such a lengthy process to be unacceptable.

"You've got women waiting 28 days with cramping and bleeding, wondering whether the pregnancy is going to be terminated," the FDA's Pendergast noted.

Meanwhile, FDA officials were said to be somewhat perplexed over what to do next if doctors and consumers chose to ignore the agency's warning.

Last month, the FDA informed Hausknecht that he should stop performing the abortions until the agency could review his protocols. If they were deemed acceptable, agency officials said they would grant a permit for him.

Though Hausknecht has submitted the information to the FDA, the agency has yet to give him the permit. On Wednesday, he declined to say whether he has resumed the study without it.

"We urge other doctors not to follow his protocol because it needed improvement," Pendergast said.

Hausknecht acknowledged that he and the FDA are having differences over his application. But he said: "I don't wish to have (a permit.) The whole world is getting into this. It's a moot point. The genie is out of the bottle."